A Study of Zomacton in Children With Growth Hormone Deficiency

Status Completed

Clinical Trial Summary

This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00884000
Study type	Interventional
Source	Ferring Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	January 2010
Completion date	July 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02243852` - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)	N/A
Completed	`NCT01440686` - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers	Phase 1
Completed	`NCT00990340` - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method	Phase 4
Completed	`NCT00235599` - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.	N/A
Completed	`NCT00149708` - Consequence of Lifetime Isolated Growth Hormone Deficiency	N/A
Completed	`NCT00459940` - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients	N/A
Completed	`NCT01157793` - A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood	Phase 4
Completed	`NCT00004365` - Study of Pituitary Size and Function in Familial Dwarfism of Sindh	N/A
Recruiting	`NCT00227253` - Chromosome 18 Clinical Research Center
Recruiting	`NCT04121780` - Growth Hormone Replacement Therapy for Retried Professional Football Players	Phase 2
Completed	`NCT02934399` - Dynamic Hormone Diagnostics in Endocrine Disease
Completed	`NCT01090778` - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)	Phase 2
Completed	`NCT00965484` - Genotropin Study Assessing Use of Injection Pen	Phase 3
Completed	`NCT01062529` - Peripheral Metabolic Effects of Somatostatin	N/A
Completed	`NCT00616278` - National Cooperative Growth Study in CKD	N/A
Completed	`NCT02693522` - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency	Phase 3
Recruiting	`NCT02908958` - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency	Phase 4
Terminated	`NCT01243892` - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device	N/A
Withdrawn	`NCT00638287` - Inter-Assay Growth Hormone and IGF-I Variability	N/A
Completed	`NCT00957671` - Anterior Pituitary Hormone Replacement in Traumatic Brain Injury	Phase 4